Reduced-pressure, compression systems and apparatuses for use on a curved body part

ABSTRACT

A system for providing a force to a desired area on a curved body part of a person includes a dressing assembly shaped and configured to be placed on the desired area of the person, a releaseable circumferential member surrounding the curved body part that holds the dressing assembly against the desired area, a sealing subsystem for providing a fluid seal over the dressing assembly and the person&#39;s skin, and a reduced-pressure subsystem for providing a reduced pressure to the dressing assembly. When reduced pressure is supplied, the system generates the force against the desired area on the curved body part.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/252,605, filed Apr. 14, 2014, which is a continuation of U.S. patentapplication Ser. No. 13/253,711 entitled “Reduced-Pressure, CompressionSystems And Apparatuses For Use On A Curved Body Part”, filed Oct. 5,2011, now U.S. Pat. No. 8,722,959 which issued on May 13, 2014, which isa continuation of U.S. patent application Ser. No. 12/475,301, entitled“Reduced-Pressure, Compression Systems And Apparatuses For Use On ACurved Body Part,” filed May 29, 2009, now U.S. Pat. No. 8,129,580 whichissued on Mar. 6, 2012; which claims the benefit, under 35 USC § 119(e),of the filing of U.S. Provisional Patent Application Ser. No.61/144,067, entitled “Reduced-Pressure, Compression System and Apparatusfor use on a Joint,” filed Jan. 12, 2009; which claims priority fromU.S. Provisional Patent Application Ser. No. 61/121,362, entitled“Reduced-Pressure Wound treatment System Employing an AnisotropicDrape,” filed Dec. 10, 2008; which claims priority from U.S. ProvisionalPatent Application Ser. No. 61/057,802, entitled “Reduced-PressureDressing Assembly For Use in Applying a Closing Force,” filed May 30,2008; which claims priority from U.S. Provisional Patent ApplicationSer. No. 61/057, 803, entitled “Reduced-Pressure, Linear-Wound TreatmentSystem,” filed May 30, 2008; which claims priority from U.S. ProvisionalPatent Application Ser. No. 61/057,807, entitled “Reduced-pressureSurgical Wound Treatment System,” filed May 30, 2008; which claimspriority from U.S. Provisional Patent Application Ser. No. 61/057,808,entitled “See-Through, Reduced-Pressure Dressing,” filed May 30, 2008;which claims priority from U.S. Provisional Patent Application Ser. No.61/057,810, entitled “Reduced-Pressure, Compression System and Apparatusfor use on a Joint,” filed May 30, 2008; which claims priority from U.S.Provisional Patent Application Ser. No. 61/057,800, entitled“Reduced-Pressure, Compression System and Apparatus for use on a CurvedBody Part,” filed May 30, 2008; which claims priority from U.S.Provisional Patent Application Ser. No. 61/057,798, entitled “DressingAssembly For Subcutaneous Wound treatment Using Reduce Pressure,” filedMay 30, 2008; which claims priority from U.S. Provisional PatentApplication Ser. No. 61/057,797, entitled “Reduced-Pressure, CompressionSystem and Apparatus for use on Breast Tissue,” filed May 30, 2008; andwhich claims priority from U.S. Provisional Patent Application Ser. No.61/057,805, entitled “Super-Absorbent, Reduced-Pressure Wound Dressingand System,” filed May 30, 2008. All of the patent applications listedin this paragraph are hereby incorporated by reference for all purposes.

BACKGROUND

The present invention relates generally to medical treatment systems,and more particularly, to reduced-pressure wound treatment systems.

Physicians perform millions of surgical procedures each year around theworld. Many of the procedures are performed as open surgery and anincreasing number are performed using minimally invasive surgery, suchas endoscopic, arthroscopic, and laparoscopic procedures. As oneexample, the American Society for Aesthetic Plastic Surgery reports thatthere were more than 450,000 liposuction procedures in the United Statesin 2007.

Surgical procedures involve acute wounds, e.g., an incision, in the skinand related tissue. In many instances, the incision is closed at theconclusion of the procedure using a mechanical apparatus, such asstaples or suture, or closed using adhesives. Thereafter, the wound isoften merely covered with a dry, sterile bandage. Of course, there isusually more disruption than just at the epidermis.

With many surgical procedures, particularly those done with minimallyinvasive techniques, much of the disruption or damage is below theepidermis, or at a subcutaneous level. Again, as one example, in onetype of liposuction procedure, after the introduction of a tumescentfluid (saline, mild painkiller, and epinephrine), the surgeon will use atrocar and cannula with suction to remove fatty areas. In doing so, itis not uncommon to have subcutaneous voids and other tissue defectsformed at tissue sites remote from the incision through which thecannula was placed or other incisions through which equipment wasplaced. The damaged tissue will need time and care to heal and poses anumber of potential complications and risks including edema, seroma,hematoma, further bruising, and ecchymosis to name some.

BRIEF SUMMARY

According to one illustrative embodiment, a system for providing a forceto a desired treatment area on a curved body part of a person includes adressing assembly for placing on the desired treatment area of theperson. The dressing assembly has a longitudinal portion with a firstend and a second end. The dressing assembly also includes an interiorsurface member having a first surface and a second, inward-facingsurface and a dressing bolster having a first surface and a second,inward-facing surface. The second, inward-facing surface of the dressingbolster is disposed against the first surface of the interior surfacemember. The system further includes a releaseable circumferential membercoupled to the first end and second end of the dressing assembly, asealing subsystem for providing a fluid seal over the dressing assembly,and a reduced-pressure subsystem for providing a reduced pressure to thedressing assembly.

According to one illustrative embodiment, a system for providing a forceto a desired treatment area on a curved body part of a person includes adressing assembly for placing on the desired treatment area of theperson. The dressing assembly has a longitudinal portion with a firstend and a second end. The dressing assembly includes a first materialhaving a first surface and a second, inward-facing surface and a secondmaterial having a first surface and a second, inward-facing surface. Thesecond, inward-facing surface of the first material is disposed againstthe first surface of the second material. The system further includes areleaseable circumferential member coupled to the first end and secondend of the dressing assembly and a reduced-pressure subsystem forproviding a reduced pressure to the dressing assembly.

According to one illustrative embodiment, a system for providing acompressive force to a desired treatment area on a person's torsoincludes a dressing assembly shaped and configured to be placed on atleast a portion of the person's torso and a releasable circumferentialconnector for holding the dressing assembly against the torso. Thecircumferential connector and the dressing assembly include acircumferential member. The system further includes a sealing subsystemfor providing a fluid seal over the dressing assembly and the person'sepidermis and a reduced-pressure subsystem for providing reducedpressure to the dressing assembly whereupon the system is operable togenerate a compressive force against at least a portion of the torso.

According to one illustrative embodiment, a system for providing acompressive force to a desired treatment area on a person's torsoincludes a dressing assembly for placing on the desired treatment areaof the person. The dressing assembly includes a longitudinal portionwith a first end and a second end, and a dressing bolster having a firstsurface and a second, inward-facing surface. The second, inward-facingsurface of the dressing bolster is disposed against the first surface ofthe interior surface member. The dressing assembly further includes anenvelope member surrounding the dressing bolster. The envelope memberincludes an interior surface member having a first surface and a second,inward-facing surface, and an exterior surface member having a firstsurface and a second, inward-facing surface. The second, inward-facingsurface of the exterior surface member is disposed proximate the firstsurface of the dressing bolster. The dressing bolster is formed from abolster material having a density greater than 25 kg/m3. the systemfurther includes a releaseable circumferential member coupled to thefirst end and second end of the dressing assembly and a sealingsubsystem for providing a fluid seal over the dressing assembly and theperson's epidermis. The sealing subsystem includes an over-drape thatextends over the exterior surface member, and a sealing apparatus forproviding a fluid seal over a person's epidermis and the over-drape.

According to one illustrative embodiment, a method of manufacturing asystem for providing a compressive force to a desired treatment area ona curved body part of a person includes the step of forming a dressingassembly shaped and configured to be placed on the desired treatmentarea of the person. The method further includes providing a releasablecircumferential connector for holding the dressing assembly against thedesired treatment area and providing a sealing subsystem for providing afluid seal over the dressing assembly and the person's epidermis.

According to one illustrative embodiment, a method of providing a forceto at least a portion of a curved body part of a person includes thesteps of: deploying a dressing assembly on the curved body part. Thedressing assembly includes an interior surface member for placing overthe desired treatment area and having a first surface and a second,inward-facing surface and a dressing bolster having a first surface anda second, inward-facing surface. The second, inward-facing surface ofthe dressing bolster is disposed against the first surface of theinterior surface member thereby sealing the dressing assembly to thecurved body part. The method further includes providing reduced pressureto the dressing assembly. The dressing bolster has a first volume (V₁)at ambient pressure and a second volume (V₂) when under reduced pressureand V₁>V₂.

According to one illustrative embodiment, a method for providing a forceto a curved body part includes the step of: placing a dressing assemblyagainst a desired area. The dressing assembly has a longitudinal portionwith a first end and a second end. The method further includesreleseably coupling the first end to the second end to hold thelongitudinal portion of the dressing assembly against the patient in thedesired treatment area; fluidly coupling a reduced-pressure source tothe dressing assembly; and activating the reduced pressure source toprovide reduced pressure to the dressing assembly. The dressing assemblyis placed under reduced pressure and contracts to form a directed force.

Other objects, features, and advantages of the illustrative embodimentswill become apparent with reference to the drawings and the detaileddescription that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention may be obtainedby reference to the following Detailed Description when taken inconjunction with the accompanying Drawings wherein:

FIG. 1 is a schematic, perspective view of a portion of an illustrativeembodiment of a reduced-pressure system shown on a person's torso;

FIG. 2 is a schematic, perspective view, with a portion in crosssection, of an illustrative embodiment of a reduced-pressure systemshown over an incision and above undermined subcutaneous tissue;

FIG. 3 is a cross-section of a portion of an illustrative embodiment ofa reduced-pressure system shown on intact skin and over an area ofundermined subcutaneous tissue;

FIG. 4 is schematic, cross-section of a portion of an illustrativeembodiment of a reduced-pressure system shown applied on a torso of aperson;

FIG. 5 is schematic, cross-section of a portion of an illustrativeembodiment of a reduced-pressure system shown applied on a torso of aperson;

FIG. 6 is an anterior, schematic, perspective view of a portion of anillustrative embodiment of a reduced-pressure system shown on a torso;

FIG. 7 is a posterior, schematic, perspective view of a portion of theillustrative system shown in FIG. 6;

FIG. 8 is a schematic cross-section of a portion of an illustrativeembodiment of a reduced-pressure, compression system;

FIG. 9 is a schematic perspective view showing a bolster material;

FIG. 10 is an anterior, schematic, perspective view of an illustrativeembodiment of a brassiere for providing support to breast tissue;

FIG. 11 is a cross section of the brassiere of FIG. 10 taken from oneside;

FIG. 12 is an anterior, schematic, perspective view of the brassiere ofFIGS. 10-11 with a portion of the brassiere released to show a backportion of the brassiere;

FIG. 13 is a schematic cross-section of a portion of the brassiere ofFIGS. 10-12; and

FIG. 14 is a schematic cross section of a portion of the brassiere ofFIGS. 10-12 showing an illustrative, alternative aspect.

DETAILED DESCRIPTION

In the following detailed description of illustrative embodiments,reference is made to the accompanying drawings that form a part hereof,and in which is shown, by way of illustration, specific embodiments inwhich the invention may be practiced. These embodiments are described insufficient detail to enable those skilled in the art to practice theinvention, and it is understood that other embodiments may be utilizedand that logical structural, mechanical, electrical, and chemicalchanges may be made without departing from the spirit or scope of theinvention. To avoid detail not necessary to enable those skilled in theart to practice the invention, the description may omit certaininformation known to those skilled in the art. The following detaileddescription is, therefore, not to be taken in a limiting sense, and thescope of the present invention is defined only by the appended claims.

Referring to FIG. 1, a system 2 for providing a force to a desiredtreatment area 3 on a person's torso 4 is shown. The system 2 may beapplied in any situation in which support is desired for a given portionof a person's body such as the torso, an arm, leg, or other curved bodypart, but is described in the context of the torso 4. The system 2 maybe applied when a force is desired for therapeutic reasons, such asproviding a compression force, or inward force (or tangential force),and a lifting force, or upward force, to a desired treatment area whileoptionally removing fluids, such as exudates. The system 2 may beapplied to treat subcutaneous tissue, treat surface tissue, or providesupport. As used herein, subcutaneous means tissue at least as deep asthe subcutaneous tissue, but also may include deeper tissues, includingorgans. Unless otherwise indicated, as used herein, “or” does notrequire mutual exclusivity. The system 2 may be applied simply whensupport is desired for cosmetic reasons or for any reason at all.

The system 2 allows support to be given to a portion of a person's bodywith relative ease, and the system 2 allows various sizes of body partsto be accommodated by a single system or apparatus thereby reducing theneed for large inventories. When used with a wound, the system 2 maykeep the wound dry, reduce dead space formation, improve perfusion,reduce seroma and hematoma formation, and reduce bruising and edemasecondary to certain surgical procedures. The system 2 also providescomparative comfort for the patient or person using the system 2. Theforce developed by system 2 may be varied by varying the reducedpressure delivered to the system 2, and a feedback loop may be used toallow automated adjustments of reduced pressure to maintain a desiredcompressive force on a treatment site even as swelling increases ordecreases.

Referring now to FIG. 2, an illustrative system 10 for treatingundermined subcutaneous tissue in a peri-incisional region according toone illustrative embodiment is presented. The system 10 is shown in aperi-incisional region around an incision 12, which is through epidermis14, or skin, and dermis 16 and reaches into a hypodermis, orsubcutaneous tissue 18. The subcutaneous tissue 18 may include numeroustissue types such as fatty tissue or muscle. The undermined subcutaneoustissue site 20 is shown extending from incision 12 and includes, in thisinstance, subcutaneous defect or void 22. The undermined subcutaneoustissue 20 is often caused by surgical procedures such as liposuction.The undermined subcutaneous tissue 20 may include voids, such as thevoid 22, open spaces, and various defects that can be troublesome for anumber of reasons. For example, the void 22 may allow fluids to buildand that may result in edema. The term “fluid” as used herein generallyrefers to gas or liquid, but may also include any other flowablematerial, including but not limited to gels, colloids, and foams.

The incision 12 may be closed using any closing device such as staples,sutures, or adhesive, but is shown in this illustrative embodiment witha suture 13. The system 10 typically is for treating an area and, inparticular, is typically for treating a subcutaneous tissue site 20 andthe tissue around subcutaneous tissue 20, but the system 10 may also beused to treat the more limited area of the incision 12.

The system 10 includes a dressing assembly 30, which includes a shapeddressing bolster 32 (or dressing bolster), a sealing subsystem 60, and areduced-pressure subsystem 80. The system 10 develops a net compressiveforce, represented by reference numerals 24, that is realized at thesubcutaneous tissue 20. As described further below, the shaped dressingbolster 32 may be shaped and configured to allow the compressive force24 to be distributed fairly evenly over the patient's epidermis 14 andbeneath the epidermis 14. Otherwise, if there are areas of substantiallyincreased force as compared to other areas, skin irritation may result.The system 10 may also be operable to develop an inward force (orclosing force), i.e. towards an interior portion of dressing assembly30. The inward force is represented by reference numerals 26. The inwardforce 26 may remain substantially within the plane of the epidermis 14.In other words, the inward force 26 operates mainly within the epidermis14. In addition, the system 10 is operable to deliver reduced pressureto the incision 12. The reduced pressure may be realized at the level ofthe subcutaneous void 22 to help approximate—bring together—the tissuesin that region as well as to help remove any air or any other fluids,e.g., exudates.

The dressing assembly 30 includes the shaped dressing bolster 32, whichhas a first side 34 and a second, inward (tissue-facing) side 36. Theshaped dressing bolster 32 may be sized and shaped to substantiallymatch the estimated area of undermined subcutaneous tissue 20 although alarger or smaller size may be used. The shaped dressing bolster 32 has aperipheral edge 38. The shaped dressing bolster 32 may be made of anumber of different bolster materials. In one illustrative embodiment,the shaped dressing bolster 32 is made from a porous and permeablefoam-like material and, more particularly, a reticulated, open-cellpolyurethane or polyether foam that allows good permeability of woundfluids while under a reduced pressure. One such foam material that hasbeen used is the VAC® Granufoam® material that is available from KineticConcepts, Inc. (KCI) of San Antonio, Tex. Any material or combination ofmaterials might be used for the bolster material provided that thebolster material is operable to distribute the reduced pressure andprovide the desired forces.

The shaped dressing bolster 32 may be a manifold that is sized andshaped to distribute forces evenly and to distribute reduced pressure.The term “manifold” as used herein generally refers to a substance orstructure that is provided to assist in applying reduced pressure to,delivering fluids to, or removing fluids from a tissue site. Themanifold typically includes a plurality of flow channels or pathwaysthat are interconnected to improve distribution of fluids provided toand removed from the tissue site around the manifold. The manifold maybe a biocompatible material that is capable of being placed in contactwith the tissue site and distributing reduced pressure to the tissuesite. Examples of manifolds may include, for example, withoutlimitation, devices that have structural elements arranged to form flowchannels, such as, for example, cellular foam, open-cell foam, poroustissue collections, liquids, gels, and foams that include, or cure toinclude, flow channels. The manifold may be porous and may be made fromfoam, gauze, felted mat, or any other material suited to a particularbiological application. Other embodiments might include “closed cells.”In some situations, the manifold may also be used to distribute fluidssuch as medications, antibacterials, growth factors, and varioussolutions to the tissue site. Other layers may be included in or on themanifold, such as absorptive materials, wicking materials, hydrophobicmaterials, and hydrophilic materials.

The reticulated pores of the Granufoam® material, that are in the rangefrom about 400 to 600 microns, are helpful in carrying out themanifolding function, but other materials may be used. The density ofthe medical bolster material, e.g., Granufoam® material, is typically inthe range of about 1.3 lb/ft³-1.6 lb/ft³ (20.8 kg/m³-25.6 kg/m³). Amaterial with a higher density (smaller pore size) than Granufoam®material may be desirable in some situations. For example, theGranufoam® material or similar material with a density greater than 1.6lb/ft³ (25.6 kg/m³) may be used. As another example, the Granufoam®material or similar material with a density greater than 2.0 lb/ft³ (32kg/m³) or 5.0 lb/ft³ (80.1 kg/m³) or even more may be used. The moredense the material is, the higher compressive force that may begenerated for a given reduced pressure. If a foam with a density lessthan the tissue at the tissue site is used as the medical bolstermaterial, a lifting force may be developed. In one illustrativeembodiment, a portion, e.g., the edges, of the dressing assembly mayexert a compressive force while another portion, e.g., a centralportion, may provide a lifting force.

The bolster material may be a reticulated foam that is later felted tothickness of about one third (⅓) of the foam's original thickness. Amongthe many possible bolster materials, the following may be used:Granufoam® material or a Foamex® technical foam (www.foamex.com). Insome instances it may be desirable to add ionic silver to the foam in amicrobonding process or to add other substances to the bolster materialsuch as antimicrobial agents. The bolster material may be isotropic oranisotropic depending on the exact orientation of the compressive forces24 that are desired during the application of reduced pressure. Thebolster material may also be a bio-absorbable material.

The sealing subsystem 60 includes an over-drape 62 (drape) or sealingmember. The over-drape 62 may be an elastomeric material or may be anymaterial that provides a fluid seal. “Fluid seal,” or “seal,” means aseal adequate to hold reduced pressure at a desired site given theparticular reduced-pressure subsystem involved. “Elastomeric” meanshaving the properties of an elastomer and generally refers to apolymeric material that has rubber-like properties. More specifically,most elastomers have elongation rates greater than 100% and asignificant amount of resilience. The resilience of a material refers tothe material's ability to recover from an elastic deformation. Examplesof elastomers may include, but are not limited to, natural rubbers,polyisoprene, styrene butadiene rubber, chloroprene rubber,polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber,ethylene propylene diene monomer, chlorosulfonated polyethylene,polysulfide rubber, polyurethane, EVA film, co-polyester, and silicones.As non-limiting examples, the over-drape 62 may be formed from materialsthat include a silicone, 3M Tegaderm® drape material, acrylic drapematerial such as one available from Avery, or an incise drape material.

The over-drape 62 may be coupled to the bolster 32. The coupling mayoccur in many ways. The over-drape 62 and the bolster 32 may be coupledusing adhesives such as an acrylic adhesive, silicone adhesive,hydrogel, hydrocolloid, etc. The over-drape 62 and the bolster 32 mightbe bonded by heat bonding, ultrasonic bonding, and radio frequencybonding, etc. The coupling may occur in discrete patterns or morecompletely. Structural members might be added to the bond to make theover-drape 62 behave anisotropically in a desired direction, i.e. tomake an anisotropic drape material. An anisotropic drape material helpsthe dressing assembly 30 to primarily move in a given direction, i.e.only about a certain axis or axes.

In the illustrative embodiment of FIG. 2, the over-drape 62 may be sizedto extend beyond the peripheral edge 38 on an extremity 33 of the shapeddressing bolster 32 to form a drape extension 64. The drape extension 64has a first surface 66 and a second, inward-facing surface 68. Theover-drape 62 may be sealed against the epidermis 14 of the patientusing a sealing apparatus or device 69 for providing a seal. Theover-drape 62 and sealing apparatus 69 allow reduced pressure to bemaintained at the tissue site by the reduced-pressure subsystem 80. Thesealing apparatus 69 may take numerous forms, such as an adhesive 70; asealing tape, or drape tape or strip; double-side drape tape; paste;hydrocolloid; hydrogel; or other sealing means. If a tape is used, itmay be formed of the same material as the over-drape 62 with apre-applied, pressure-sensitive adhesive. The pressure-sensitiveadhesive 70 may be applied on the second surface 68 of the drapeextension 64. The adhesive 70 provides a substantial fluid seal betweenthe over-drape 62 and the epidermis 14 of the patient. The adhesive 70may have removable strips covering the adhesive 70 that are removedbefore the drape extension 64 is applied to the patient's epidermis 14.

The reduced-pressure subsystem 80 includes a reduced-pressure source 82,which can take many different forms. The reduced-pressure source 82provides a reduced pressure as a part of the system 10. Thereduced-pressure source 82 may be any device for supplying a reducedpressure, such as a vacuum pump, wall suction, or other source. Whilethe amount and nature of reduced pressure applied to a tissue site andshaped dressing bolster 32 will typically vary according to theapplication, the reduced pressure will typically be between −5 mm Hg and−500 mm Hg and more typically between −100 mm Hg and −300 mm Hg.

As used herein, “reduced pressure” generally refers to a pressure lessthan the ambient pressure at a tissue site that is being subjected totreatment. In most cases, this reduced pressure will be less than theatmospheric pressure at which the patient is located. Alternatively, thereduced pressure may be less than a hydrostatic pressure at the tissuesite. Unless otherwise indicated, values of pressure stated herein aregauge pressures. The reduced pressure delivered may be constant orvaried (patterned or random) and may be delivered continuously orintermittently. Although the terms “vacuum” and “negative pressure” maybe used to describe the pressure applied to the tissue site, the actualpressure applied to the tissue site may be more than the pressurenormally associated with a complete vacuum. Consistent with the useherein, an increase in reduced pressure or vacuum pressure typicallyrefers to a relative reduction in absolute pressure.

In order to maximize patient mobility and ease, the reduced-pressuresource 82 may be a battery-powered, single-use reduced-pressuregenerator. Such a reduced-pressure source 82 facilitates application inthe operating room and provides mobility and convenience for the patientduring the rehabilitation phase. The reduced-pressure source 82 has abattery compartment 84 and a canister region 86 with windows 88providing a visual indication of the level of fluid within the canister86. An interposed membrane filter, such as hydrophobic or oleophobicfilter, might be interspersed between a reduced-pressure deliveryconduit, or tubing, 90 and the reduced-pressure source 82.

For many procedures, it is believed that the patient would be directedto wear the system 10 for three to five days and may be directed to wearsystem 10 for 15 days or more. Still, the treatment time is a welcomedtime period in contrast to treatment with conventional compressivegarments, which are worn after many procedures today for up to sixweeks. Accordingly, the battery life and/or power provisions may need toaccommodate up to 15 days of operation. Other sources of reducedpressure may also be utilized such as V.A.C.® therapy unit, which isavailable from KCI of San Antonio, Tex., or a wall suction unit. Thereduced-pressure source 82 may also be supplied by a portable mechanicaldevice, such as a piston in a tube, depending on how much leakage thereis with the fluid seal between the shaped dressing bolster 32 and theepidermis 14.

The reduced pressure developed by the reduced-pressure source 82 isdelivered through the reduced-pressure delivery conduit 90 to areduced-pressure interface 92, which may be an elbow port 94. In oneillustrative embodiment, the port 94 is a TRAC® technology portavailable from KCI of San Antonio, Tex. The reduced-pressure interface92 allows the reduced pressure to be delivered to the sealing subsystem60 and realized within an interior portion of the sealing subsystem 60.In this illustrative embodiment, the port 94 extends through theover-drape 62 and into the shaped dressing bolster 32.

In operation, the system 10 may be applied in the operating room after asurgical procedure on the patient or at another time. The second surface36 of the shaped dressing bolster 32 is placed against the patient'sepidermis 14 with the shaped dressing bolster 32 over the underminedsubcutaneous tissue site 20 and with a portion over the incision 12. Thedressing assembly 30 may be sized for the typical application involvedin the procedure performed by a healthcare provider. The dressingassembly 30 may be sized, shaped, and configured to work with differentanatomical applications such as abdominal, chest, thighs, arms, etc.

If the over-drape 62 has not already been coupled (see otherillustrative embodiments below) to the shaped dressing bolster 32, theover-drape 62 is then placed over the first surface 34 of the shapeddressing bolster 32 with an extra portion extending beyond theperipheral edge 38 to form the drape extension 64. The drape extension64 can then be taped to the epidermis 14 (see 172 in FIG. 2) or anadhesive 70 (FIG. 1) used to form a fluid seal between the over-drape 62and the patient's epidermis 14. The fluid seal need only be adequate toallow the system 10 to hold a reduced pressure on the treatment site.The reduced-pressure interface 92 and the reduced-pressure sources 82are fluidly coupled using the reduced-pressure delivery conduit 90. Thereduced-pressure source 82 may then be activated and reduced pressuredelivered to the shaped dressing bolster 32.

As the pressure is reduced at the shaped dressing bolster 32, the shapeddressing bolster 32 compresses and contracts laterally and forms asemi-rigid substrate and, as a result, a number of beneficial forces andactions take place. The reduced pressure is transmitted further stillthrough the shaped dressing bolster 32 so that reduced pressure isexperienced at the patient's epidermis 14 at the incision 12. At leastat the early stages of the healing process, the reduced pressure isrealized through the incision 12 and into the subcutaneous tissue 20 andthe reduction of pressure helps close defects, such as subcutaneous void22, and generally provides stability to the area. The reduced pressuredelivered to the shaped dressing bolster 32 also develops thecompressive force 24 that again may provide stability and therapy. Thecompressive force 24 is more than just at the epidermis 14. Thecompressive force 24 extends down deeper and may be experienced at thelevel of subcutaneous tissue 20.

As the over-drape 62 and shaped dressing bolster 32 laterally contractunder the influence of the reduced pressure, and as the downward forceacts through the Poisson's ratio for the epidermis 14, an inward force26 develops that may help hold a closing force on the incision 12 andmay generally provide additional stability to the incision 12 ortreatment site. The inward force 26 may rely in part on friction betweenthe shaped dressing bolster 32 and the epidermis 14 to communicate theforce to the epidermis 14 and may involve force transmission from thedrape extension 64 to the epidermis 14 by way of the adhesive 70 orthrough friction if tape (172 in FIG. 2) is used. At the same time, thereduced pressure delivered to and through shaped dressing bolster 32helps to remove any exudates or other fluids from the incision 12. Thesystem 10 also allows the epidermis to be smoothed out with an evenapplication of force—it contours and smoothes the epidermis 14. Allthese actions may improve healing of the incision 12 and the underminedsubcutaneous tissue 20.

One operational concern is to avoid skin irritation in deploying andusing the system 10. Accordingly, care is taken to avoid skinirritation, such as blistering of the patient's epidermis 14, that maybe due to secondary shear, secondary strain or other effects. For thisreason, the extremity 33 of the shaped dressing bolster 32 may be shapedto provide an even distribution of compressive forces. The extremity 33is the outer, shaped portion of bolster 32 and the peripheral edge isgenerally the most outboard portion of the shaped dressing bolster 32 orthe most outboard portion that interface with patient's epidermis. Theextremity 33 may be a chamfered surface, but other shapes, e.g., anarcuate shape in system 110 (FIG. 2), may be used. Shapes that evenlydistribute the resultant forces are desired. For comparison, when adressing bolster with a square-edge is used, a “tent area” may form whenthe over-drape is applied over the dressing bolster and onto thepatient's epidermis. The “tent area” is believed to contribute to issueswith skin irritation. The “tent area” may be avoided by shaping theshaped bolster 32 or by attaching the over-drape to a side area of thedressing bolster.

The shaped edge, or extremity, of the shaped dressing bolster 32 allowsa compressive force 24 to be developed without a big “edge effect”; thatis, without causing shear or stress to rise to a level that causes skinirritation such as erythema or blistering. The shaped portion graduallydistributes the force to avoid irritation. This way of carefullyapplying the forces to the epidermis 14 to avoid irritation is generallyreferred to as “evenly distributing” the compressive force 24, but isnot strictly used in a literal sense. There may be some variation, butnot enough to cause irritation of the epidermis 14. As anotherprecaution against skin irritation, an inner layer might be addedbetween the shaped dressing bolster 32 and the patient's epidermis 14(see 857 in FIG. 11) or placed in other locations as explained inconnection with other illustrative embodiments further below.

It may be desirable to apply the system 10 in the operating room andallow the system 10 to remain on the patient until adequate healing hastaken place. In this regard, it may be desirable to form the over-drape62, the shaped dressing bolster 32, and any other layers fromsee-through materials to allow the healthcare provider to gain visualcues about the healing of the incision 12 and the underminedsubcutaneous tissue 20 without having to remove the dressing assembly30.

Referring now to FIG. 3, another illustrative embodiment of a system 110for treating undermined subcutaneous tissue in a patient is presented.The system 110 is analogous in most respects to the system 10 of FIG. 2and analogous parts are generally indicated in this embodiment byindexing the numerals by 100. In this particular illustrativeembodiment, the system 110 is placed over intact epidermis 115, i.e.,there is no incision or other linear wound in this instance. There is,however, undermined subcutaneous tissue 120 including a subcutaneousvoid 122. The system 110 helps treat the undermined subcutaneous tissue120 whether or not there is an incision.

The system 110 includes a dressing assembly 130 having a shaped dressingbolster 132. The shaped dressing bolster 132 has a first side 132 and asecond, inward-facing side 136. While the shaped dressing bolster 32 ofFIG. 2 was shown with a trapezoidal cross-section, a shaped dressingbolster 132 of FIG. 3 has a cross-section that is formed with anelliptical shape with an extremity 133 having radiused edges, or havingan arcuate edge. The shaped dressing bolster 132 may be shaped with adouble-beveled cross-section or other shape. As before, the shape of theshaped dressing bolster 132 is facilitates the even distribution of thecompressive force to an extent that skin irritation is avoided duringreduced pressure. In the illustrative embodiment of FIG. 3, a sealingapparatus 169 provides a fluid seal between an over-drape 162 andepidermis 114 of the patient. In this example, the sealing apparatus 169is a sealing tape 172.

The system 110 includes a sealing subsystem 160 to provide a fluid sealover the shaped dressing bolster 132. A reduced-pressure deliveryconduit 190 delivers reduced pressure to a reduced-pressure interface192, e.g., a port 194, that is in fluid communication with an interiorportion of the sealing subsystem 160.

In this illustrative embodiment, the ambient pressure provides a force131 on a first surface 161 of the over-drape 162 and the contraction ofthe shaped dressing bolster 132 develops a compression force 124 toprovide a net force that is experienced down into the skin and thatreaches dermis 116 and may reach other subcutaneous levels 118. At thesame time, a substantially in-plane force directed inward is developed.The inward force might be developed through two different mechanisms.First, an inward force 127 is an inward contraction force caused by theshaped dressing bolster 132 being compressed and as the shaped dressingbolster 132 compresses the shaped dressing bolster 132 is drawn inward.At the same time, as the reduced pressure is applied, the over-drape 162is drawn into the area proximate the extremity 133 as suggested by arrow128. Because a drape extension 164 is secured to the epidermis 114, thehorizontal component of the resultant force 128 would pull the epidermis114 inward as is suggested by the inward force 129.

Referring now to FIG. 4, a system 210 for treating a tissue site 220,e.g., an undermined subcutaneous tissue site, is shown on a curved bodypart 200, such as a patient's torso. The system 210 includes a dressingassembly 230 and a sealing subsystem 260. The dressing assembly 230includes a shaped dressing bolster 232. The sealing subsystem 260includes an over-drape 262 with an extension 264. The extension 264 maybe secured to the patient's epidermis 214 by a sealing apparatus, suchas an adhesive 270. A reduced-pressure source (not shown) providesreduced pressure to a reduced-pressure delivery conduit 290, whichdelivers the reduced pressure to a reduced-pressure interface 292.

The reduced-pressure interface 292 delivers the reduced pressure to theshaped dressing bolster 232. As the shaped dressing bolster 232 iscompressed under the influence of reduced pressure, a net compressiveforce 224 is developed that is delivered to the tissue site 220. In thisembodiment, an extremity 233 of the shaped dressing bolster 232 isformed with an orthogonal end. The over-drape 262 forms a “tent” area229 around a void 235. Under reduced pressure, the over-drape 262 ispulled into the void 235 and a force is thereby applied that develops aninward contracting force 226.

In the system 210, the curvature of the shaped dressing bolster 232 alsohelps develop a compressive force. A first surface 234 of the shapeddressing bolster 232 has a greater surface area than the surface area ofa second, inward-facing surface 236 of the shaped dressing bolster 232.Thus, under reduced pressure, this difference in surface areas alsofacilitates the development of a net compressive force 224.

Referring now to FIG. 5, an illustrative system 310 for treating atissue site 320, e.g., an undermined subcutaneous tissue site, ispresented. The system 310 is generally analogous in most respects to thesystem 210 of FIG. 4, and analogous parts are indicated by indexing thereference numerals of FIG. 4 by 100. The system 310 is applied to acurved body part 300, e.g., a patient's torso. The system 310 presents acompletely circumferential dressing assembly 330 deployed proximateepidermis 314.

A dressing bolster 332 is disposed against the epidermis 314 and adrape, or an over-drape 362, is used to form a sealed area containingthe dressing bolster 332. Reduced pressure is delivered through areduced-pressure conduit 390 to a reduced-pressure interface 392. Thereduced-pressure interface 392 delivers reduced pressure to the dressingbolster 332. Circumferential forces developed during the application ofreduced pressure combine in the system 310 to develop inward compressiveforces 324. The compressive forces can be higher than a flat orpartial-torso application because there is no off-loading of force tothe drape and to the skin.

Referring now to FIGS. 6-8, a system 410 for treating a treatment area412 of a patient is presented. The treatment provided in thisillustration is a force to the treatment area 412, which on thepatient's torso 404. Treatment could also include removal of fluids atan incision or incisions. For this illustrative embodiment, the desiredtreatment area 412 is shown as the abdomen of the patient. If thepatient has had, for example, tumescent liposuction, it may be desirableto use the system 410 to apply a compressive force realized at anincision or incisions, to apply a compressive force that is realized atthe dermis 416 and at undermined subcutaneous tissue 420, to provide forthe approximation of subcutaneous tissue 418 as well as stabilizing thetissue against sheer stress, and to remove any exiting fluids such astumescent fluid or exudate. The system 410 includes a dressing assembly430 that extends circumferentially at least partially around the torso404 of the patient. The dressing assembly 430 includes a dressingbolster 432, which has a first peripheral edge 439.

As shown clearly in FIG. 8, the dressing bolster 432 has a first surface434 and a second, inward-facing (or tissue-facing) surface 436. Thedressing bolster 432 distributes reduced pressure and provides a force,which may be a compression force or lifting force, to the desiredtreatment area, e.g., treatment area 412. An interior surface member440, which has a first surface 442 and a second, inward-facing surface444, may be disposed between the patient's epidermis 414 and thedressing bolster 432. The second surface 436 of the dressing bolster 432may be coupled, e.g., bonded or incorporated into, to the first surface442 of the interior surface member 440. The interior surface member 440may be independent of the dressing bolster 432. The interior surfacemember 440 may be fluid permeable or impermeable and may provide abarrier between the dressing bolster 432 and the patient's epidermis. Inone illustrative embodiment, the interior surface member 440 avoid skinirritation that might result from the dressing bolster 432 interfacingwith the patient's skin and facilitates removal sweat and other fluidsat the surface using reduced pressure.

The dressing bolster 432 may be made from any of the bolster materialsdescribed elsewhere in this application. The dressing bolster 432 mayinclude bolster material that is not uniform throughout since one maywant the dressing bolster 432 to be more rigid (and not provide as muchlift) in some places or one may want the dressing bolster 432 to be lessrigid and to develop maximum lift in some places, e.g., like at thebreasts on the brassiere embodiment below. The bolster material may bemade more or less rigid using a bolster material with varying propertiesor using two or more different materials that are combined to form thebolster material. In some applications, it may be desirable to form thebolster material from a honeycomb material such as a Supracor®fusion-bonded honeycomb material from Supracor Systems, Inc. ofSunnyvale, Calif.

The dressing assembly 430 may further include an exterior surface member446, or exterior member, which has a first side 448 and a second side450. The interior surface member 440, or interior member, and theexterior surface member 446 may be made with a pre-tensioned elasticmaterial such as a spandex material; for example, a Lycra® brandmaterial might be used. The interior surface member 440 has highcontractibility to avoid wrinkling, which would result in contactloading against the skin. Furthermore, the low friction of the materialused for the inner surface member 440 helps to reduce the possibility ofshear injury to the epidermis. Moreover, the permeability of the innersurface member 440, or layer, results in reduced-pressure transmissionto the tissue site and provides a pathway for exudate removal. Theinterior surface member 440, or interior member, and the exteriorsurface member 446 may be coupled to form an envelope surrounding thedressing bolster 432.

The second side 450 of the exterior surface member 446 may be coupled tothe first surface 434 of the dressing bolster 432. The coupling of thevarious members (e.g., surface 436 to surface 442 and surface 450 to434) may occur in many ways; a number of examples follow. One might useadhesives such as acrylic adhesive, silicone adhesive, hydrogel,hydrocolloid, etc. or might use bonding such as heat bonding, ultrasonicbonding, or radio frequency bonding, etc. The coupling may occur inpatterns or may cover the whole. Structural members may be added to thecoupling to make the member behave anisotropically in a desireddirection. In addition, struts or other mechanical elements may besupplied within the bolster to change the compression andcharacteristics of the dressing bolster 432.

The dressing assembly 430 is shown in FIGS. 6 through 8 with asubstantially rectangular cross-section, but other shapes may beutilized to provide more of a vertical lifting force (vertical for theorientation shown in FIGS. 6 and 7). While the dressing bolster 432 isshown as an integral member, the dressing bolster 432 may also be formedwith different sections of bolster material, each having distinctsupplies of reduced-pressure, and may even have a section with positivepressure. Concerning the latter, one or more sealed chambers may beadded to which a positive pressure could be provided to helpredistribute loading or to add structural elements.

The dressing bolster 432 and any additional layers such as the interiorsurface member 440 and the exterior surface member 446 may be coveredwith an over-drape 462, which is part of a sealing subsystem 460. Theover-drape 462 may extend beyond peripheral edges 438 and 439 to formdrape extension 464, which has a first side 466 and a second side 468. Afluid seal may be formed between the drape extension 464 and thepatient's epidermis 414 by using a sealing apparatus 469, such as asealing tape, or drape tape 471, an adhesive (see adhesive 5 in FIG. 1),paste, hydrocolloid, hydrogel, or other sealing means. The drape tape471 includes an adhesive 473. In some applications, a gasket materialmight be added between the epidermis 414 and the dressing bolster 432 orthe over-drape 462. In another embodiment, the over-drape 462 may beapplied only on the first side of the dressing bolster 432, and then awide drape tape used to seal the edges, or peripheral portion, of thedressing bolster 432 with or without extensions 464.

The sealing subsystem 460 provides a fluid seal, or otherwise allows thesystem 410 to maintain reduced pressure at the desired treatment site412. The sealing subsystem 460 preferably includes the over-drape 462and the sealing apparatus 469. While described as forming a fluid seal,there may in fact be some leakage and the resultant small air leaksactually provide a low velocity airflow throughout the dressing assembly430 that is distributed and helps to remove moisture. In an alternativeembodiment, instead of using the over-drape 462, the exterior surfacemember 446 may be made to have an airtight exterior portion and drapetape may be directed to cover the edges of the bolster material as wellan other portions that are not otherwise sealed.

A reduced-pressure subsystem 480 is shown in part and is analogous tothe reduced-pressure subsystems of previously presented embodiments,e.g., 80 of FIG. 2. The reduced-pressure subsystem 480 includes areduced-pressure interface 492, such as elbow port 494, that allows thereduced-pressure source to deliver reduced pressure through areduced-pressure conduit 479 into the dressing assembly 430 and, inparticular, into the dressing bolster 432. The reduced-pressuresubsystem 480 may be controlled so as to vary the pressure to provide aconstant level of compression as the patient's size changes due to edemadecreasing. The reduced-pressure source may supply a constant reducedpressure or a variable reduced pressure. As with other embodimentsdescribed above, the reduced-pressure source may take many differentforms including those mentioned elsewhere herein.

As shown clearly in FIG. 7, the dressing assembly 430 may include atransition area 452 on a portion of the dressing bolster 432. Thetransition area 452 may be tapered or otherwise shaped to reduce thethickness and increase flexibility and maximize shear compliance at theborders. This may help to distribute any concentrated shear loads suchas those caused by contraction of the dressing assembly 430, patientmobility, and load concentrations caused by the discontinuity ofstiffness between the dressing/splinted areas and the unsupporteddermis. The transition area 452 may transition to one or more connectionpieces 454, or joining elements 454.

A portion of the joining elements 454 may include fasteners 456, whichmay be a hook and loop fastener, clasps, or other means of connectingtwo portions of the joining elements 454. The joining elements 454 andfasteners 456 form a circumferential connector and with the dressingassembly 430 complete a path around the curved body part or form acompleted, releasable circumferential member 458. Thus, the releasablecircumferential member 458 extends around the patient's torso 404 toallow the releasable circumferential member 458 to be held against thetorso 404 and, in particular, holds bolster 432 against the desiredtreatment area 412 even before the reduced pressure is delivered by thereduced-pressure subsystem 480. Additional drape tape may be used toprovide a fluid seal over the joining elements 454 and fasteners 456.

The transition area 452 may include a first end 453 and a second end 455of the dressing assembly 430 and in particular the ends of alongitudinal portion 457 that is shown surrounding the patient's torso404. The two ends are thus brought together and releaseably held by thereleasable circumferential member 458, which includes the joiningelements 454 and fasteners 456.

The differences in surface areas of the first surface 434 and secondsurface 436 of the dressing bolster 432 contributes to the production ofa net compressive (inward) force. The net compressive force increaseslinearly with the increase in the ratio of the circumference of thefirst surface 434 of the dressing bolster 432 to the second surface 436of the dressing bolster 432. Thus, to have a greater compressiondeveloped, the dressing bolster 432 may be made thicker to increase theratio. The bending stiffness of the dressing bolster 432 may alsoinfluence the delivery of the developed compression force. The netcompressive force is distributed fairly uniformly if the dressing 430has a low-bending stiffness. With reference briefly to FIG. 9, the lowelastic stiffness along a second axis, which is parallel to 542, and thefirst axis, which is parallel to 540, contributes to reducing thebending stiffness of the dressing bolster 532.

Returning now to FIG. 6-8, in operation, the dressing assembly 430 isplaced around the curved body part, e.g., the torso 404, of the patientwith the dressing bolster 432 against the desired treatment area 412.The releasable circumferential connector 458 is utilized (i.e. joiningelements 454 and fasteners 456 are activated) to form the completedreleasable circumferential member. The reduced-pressure subsystem 480may be activated so that the reduced-pressure subsystem 480 deliversreduced pressure to the sealing subsystem 460 causing the reducedpressure to be delivered to the dressing bolster 432. The dressingbolster 432 may then compress and collapse under the reduced pressure todeliver the support force to the desired treatment area 412. The supportforce may include a compressive force, which acts into the patient'storso and down into the epidermis 14, dermis 416, and down tosubcutaneous levels 418 to the undermined subcutaneous tissue 420. Thenet compressive force for one segment is shown in FIG. 8 with referencenumeral 424. A lateral force 426, i.e., toward peripheral edge 439, orlifting or upward force 426, may also be developed.

Referring now to FIG. 9, a portion of a dressing bolster 532 is shownwhich is made from an anisotropic material. One anisotropic materialthat may be used is AirX compression material, or fabric, available fromthe Tytex Group (www.tytex.com). The dressing bolster 532 has a firstsurface 534 and a second surface 536. It also has a top portion 537which would be closest to the person's head for the embodiment shown inFIGS. 6 and 7, and a bottom portion 539 which would be closest to theperson's feet for the embodiment shown in FIGS. 6 and 7. For descriptionpurposes, the dressing bolster 532 has three axes that are parallel toreference lines 540, 542, and 544, respectively. The material of thedressing bolster 532 is potentially anisotropic, which means that itwill have different mechanical properties along different axes. Forexample, the compressive modulus may differ between at least two of thefirst, second, and third axes. In one illustrative embodiment, when itis desirable to provide an enhanced force, an anisotropic material maybe selected and oriented to extend or to contract preferentially alongone or more axes. This may be particularly desirable in applying asimilar system to breast tissue as will now be considered.

Referring to FIGS. 10-14, a system 610 for providing a support force tobreast tissue is presented. The system 610 includes a therapeuticbrassiere 612 to provide support to breast tissue 614 in a breast area616 on an upper portion of a patient's torso 604. Support may beprovided in a defined support area 618 near or on the breast tissue 614,which may have been the subject of a surgical procedure, such as apartial or total mastectomy or a breast augmentation procedure. In theevent of a mastectomy, the support area 618 may support remaining breasttissue.

The system 610 includes a dressing assembly 630, which includes adressing bolster 632 having a first surface 634 and a second,inward-facing surface 636. The dressing assembly 630 may include aninterior surface member 638 having a first surface 640 and a second,inward-facing surface 642. The interior surface member 638 may becoupled on a first surface 640 to the second surface 636 of the dressingbolster 632. The dressing assembly 630 may also include an exteriorsurface member 644, which has a first surface 646 and a second,inward-facing surface 648. The exterior surface member 644 may becoupled on a second surface to the first surface 634 of the bolster 632.

A sealing subsystem 660 provides a fluid seal sufficient to maintain areduced pressure against the patient's epidermis in the desired supportarea 618 when under a reduced pressure from a reduced-pressure subsystem680. The sealing subsystem 660 may take a number of different forms. Thepresent embodiment includes an over-drape 662 that covers the dressingbolster 632 and may extend beyond peripheral edges 650 of the dressingbolster 632 to form extensions 664 to which a sealing apparatus 667 maybe applied to form the fluid seal with the epidermis. The sealingapparatus 667 may take numerous forms such as adhesive, a sealing tape668 or strip, double-sided sealing tape, paste, hydrocolloid, hydrogel,or other sealing means. The sealing apparatus 667 might also involveadditional elements as shown in FIG. 13.

Referring now to FIG. 13, a closing apparatus 667 may simply be a tape668 or an adhesive as previously mentioned or may further include asealing bolster 670 which may be under more tension than the dressingbolster 632. The sealing bolster 670 has a portion of the over-drape 662over the sealing bolster 670 and may form a compartment to whichreduced-pressure subsystem 680 delivers reduced pressure or may befluidly connected to the dressing bolster 632 to receive reducedpressure from the reduced-pressure subsystem 680.

Referring now to FIG. 14, an illustrative, alternative embodiment ofsealing apparatus 667 is presented. In this embodiment, the exteriorsurface member 644 and interior surface member 638 are placed adjacentto one another beyond the peripheral edge 650. The second surface 648 ofthe exterior surface member 644 and the first surface 640 of theinterior surface member 638 may be coupled to one another by any knownmeans. The members may be coupled in many different ways including oneof the following: using adhesives such as by acrylic adhesive, siliconeadhesive, hydrogel, hydrocolloid, etc; bonded by heating bonding,ultrasonic bonding, and radio frequency bonding, etc.; or other means.The coupling may occur in patterns or more completely. Structure mightbe added to the bond to make the material behave anisotropically in adesired direction. The embodiment in FIG. 14 shows an adhesive strip 674applied between the second surface 642 of the interior surface member638 and the patient's epidermis 611. Before the adhesive strip 674 isapplied against the epidermis 611, the adhesive strip 674 may be coveredwith a removable backing or strip.

Referring now primarily to FIGS. 10-12, support forces delivered to thesupport area 618 will now be explained in terms of the therapeuticbrassiere 612. The brassiere 612 is formed as previously described inconnection with the dressing assembly 630 and includes a first breastcup 682 and a second breast cup 684. In forming the breast cups 682 and684 it may be necessary to add one or more seams 686. Each breast cup682, 684 forms a pocket, such as pocket 688 shown in FIG. 11. The pocket688 is for receiving breast tissue 614, or in the case of a mastectomy,may receive a temporary, post-surgical prosthetic, such as a silicon gelinsert covered with a super absorbent material for assisting in theprocess of collecting exudates and helping to apply pressure to anunderlying wound. In an alternative embodiment, a single cup may beformed that covers both breasts or more generally a portion of thepatient's chest.

The therapeutic brassiere 612 might be bifurcated to have separatebolsters with separate sealing subsystems for each breast cup 682, 684so that different pressure levels can be supplied to each breast cup682, 684 to accommodate different sizes or situations. For example, ifone breast has been the subject of a mastectomy and the other has not,different reduced pressures may be desired.

Referring now primarily to FIG. 12, the therapeutic brassiere 612 mayhave a transition area 652 that includes a joining element 654. Thejoining element 654 may be a web material and one or more fasteners 656,which couple with a receiving fastener on the opposite transition area652 (not explicitly shown, but analogous to fastener 456 in FIG. 7). Thefasteners 656 may be hook and loop members, zipper members, snaps, orother means. It may be desirable in some situations to apply drape tapeover the top of the fasteners 456 to provide an adequate fluid seal. Thereduced-pressure subsystem 680, which is only shown in part, delivers areduced pressure through a reduced-pressure conduit 687, which is influid communication with the dressing bolster 632 through areduced-pressure interface 692, such as an elbow port 694.

In operation, the system 610 is utilized by placing the therapeuticbrassiere 612 on the torso 604 so that at least a portion of the bolster632 is proximate the breast tissue 614, and preferably proximate thesupport area 618. The dressing assembly 630 along with the joiningelement 654 and fasteners 656 form a releasable circumferentialconnector 698 that holds the therapeutic brassiere 612 in place evenbefore the reduced pressure from the reduced-pressure subsystem 680 isapplied. Once the therapeutic brassier 612 is in place, thereduced-pressure subsystem 680 is activated and reduced pressure isdelivered through the reduced-pressure interface 692 to the dressingbolster 632. The dressing bolster 632 collapses and contracts under theinfluence of the reduced pressure and thereby causes tension to developthroughout the circumferential connector 698 and provides a compressionforce and an element of a supporting (upward) force to the support area618 or to the breast tissue 614.

The systems and apparatuses have been shown applied on various bodyparts, e.g., abdomen and breast, but other applications are included.For example, the system may be used on a thigh of a person in which casethe bolster assembly might be held in place by a pair of shorts similarto biking shorts. As another example, the systems and apparatusesdescribed for breast tissue might be modified to form a large singlefront cup that could be used to lift and support a pannus or otherhanging flap of tissue. As still one more example, a reduced-pressurecup made in a analogous style to that presented for the breast tissuecould be used for testicular support after surgery and might beincorporated into shorts.

According to another illustrative embodiment, a method of providing aforce to at least a portion of a curved body part of a person includesthe step of deploying a dressing assembly on the curved body part. Thedressing assembly includes an interior surface member for placing overthe desired treatment area and having a first surface and a second,inward-facing surface. The dressing bolster has a first surface and asecond, inward-facing surface. The second, inward-facing surface of thedressing bolster is disposed against the first surface of the interiorsurface member. The dressing assembly may be sealed to the curved bodypart. The method further includes providing reduced pressure to thedressing assembly. When reduced pressure is applied, the dressingbolster goes from a first volume (V₁) at ambient pressure to a secondvolume (V₂) at reduced pressure. In other words, the first volume isgreater than the second: V₁>V₂. As the volume changes, a directed forceis developed that may include a compressive portion, a lifting portion,or a inward closing portion.

Although the present invention and its advantages have been disclosed inthe context of certain illustrative, non-limiting embodiments, it shouldbe understood that various changes, substitutions, permutations, andalterations can be made without departing from the scope of theinvention as defined by the appended claims. It will be appreciated thatany feature that is described in a connection to any one embodiment mayalso be applicable to any other embodiment.

1.-44. (canceled)
 45. A system for providing a force to a treatment areaon a person, the system comprising: a dressing assembly for placing onthe treatment area, the dressing assembly having a longitudinal portionwith a first end and a second end; wherein the dressing assemblycomprises: an interior surface member having a first surface and asecond, inward-facing surface, and a dressing bolster having a firstsurface and a second, inward-facing surface, wherein the second,inward-facing surface of the dressing bolster is disposed against thefirst surface of the interior surface member; and a releaseableconnector coupled to the first end and second end of the dressingassembly, the releaseable connector adapted to releaseably couple thefirst end of the dressing assembly to the second end of the dressingassembly.
 46. The system of claim 45 wherein the dressing bolster isformed from a bolster material having a density greater than 25 kg/m³.47. The system of claim 45 wherein the dressing assembly furthercomprises an exterior surface member having a first surface and asecond, inward-facing surface, wherein the second, inward-facing surfaceof the exterior surface member is disposed against the first surface ofthe dressing bolster.
 48. The system of claim 45 wherein the dressingbolster comprises an anisotropic bolster material having a first,second, and third axes, and wherein compressive modulus differ betweenat least two of the first, second, and third axes.
 49. The system ofclaim 45 wherein the interior surface member comprises an elasticmaterial.
 50. The system of claim 45 wherein the interior surface membercomprises spandex.
 51. The system of claim 45 wherein the dressingassembly comprises: an exterior surface member having a first surfaceand a second, inward-facing surface, wherein the second, inward-facingsurface of the exterior surface member is disposed against the firstsurface of the dressing bolster; and wherein the exterior surface membercomprises an elastic material.
 52. The system of claim 45 wherein thedressing assembly comprises: an exterior surface member having a firstsurface and a second, inward-facing surface, wherein the second,inward-facing surface of the exterior surface member is disposed againstthe first surface of the dressing bolster; and wherein the exteriorsurface member comprises spandex.
 53. The system of claim 45 wherein thedressing assembly further comprises: an exterior surface member having afirst surface and a second, inward-facing surface, wherein the second,inward-facing surface of the exterior surface member is coupled to thefirst surface of the dressing bolster.
 54. The system of claim 45wherein the releaseable connector comprises: a joining element and areleasable fastener.
 55. The system of claim 45, further comprising asealing subsystem for providing a fluid seal over the dressing assembly,wherein the sealing subsystem comprises: an over-drape that extends overthe dressing assembly; and a sealing apparatus for providing the fluidseal between the person's epidermis and the over-drape.
 56. The systemof claim 45, further comprising a reduced-pressure subsystem forproviding a reduced pressure to the dressing assembly, wherein thereduced-pressure subsystem comprises: a reduced-pressure source forproviding reduced pressure; a reduced-pressure interface coupled to thesealing subsystem; and a reduced-pressure delivery conduit for providingreduced pressure from the reduced-pressure source to thereduced-pressure interface.
 57. The system of claim 45, wherein thedressing assembly comprises: an exterior surface member sized to extendover the dressing bolster and having a first surface and a second,inward-facing surface, wherein the second, inward-facing surface of theexterior surface member is disposed against the first surface of thedressing bolster; further comprising a sealing subsystem for providing afluid seal over the dressing assembly, wherein the sealing subsystemcomprises: an over-drape that extends over the dressing bolster, and asealing apparatus for providing the fluid seal between the person'sepidermis and the over-drape; and further comprising a reduced-pressuresubsystem for providing a reduced pressure to the dressing assembly,wherein the reduced-pressure subsystem comprises: a reduced-pressuresource for providing reduced pressure, a reduced-pressure interfacecoupled to the sealing subsystem, and a reduced-pressure deliveryconduit for providing reduced pressure from the reduced-pressure sourceto the reduced-pressure interface.
 58. A system for providing a force toa treatment area on a person, the system comprising: a dressingassembly, the dressing assembly having a longitudinal portion with afirst end and a second end; wherein the dressing assembly comprises: afirst material having a first surface and a second, inward-facingsurface, and a second material having a first surface and a second,inward-facing surface, wherein the second, inward-facing surface of thefirst material is disposed against the first surface of the secondmaterial; a releaseable connector coupled to the first end and thesecond end of the dressing assembly and adapted to releaseably couplethe first end of the dressing assembly to the second end of the dressingassembly; and a reduced-pressure subsystem for providing a reducedpressure to the dressing assembly.
 59. The system of claim 58 whereinthe first material is an elastic material and the second material is abolster material.
 60. The system of claim 58 wherein the dressingassembly is operable to generate a directed force under reducedpressure.
 61. The system of claim 58 wherein the dressing assembly isoperable to generate a lifting force under reduced pressure.
 62. Asystem for providing a compressive force to a desired treatment area ona patient, the system comprising: a dressing assembly shaped andconfigured to be placed proximate to the treatment area; a releasableconnector for holding the dressing assembly against the patient, whereinthe releaseable connector comprises a joining element and a releasablefastener; a sealing subsystem for providing a fluid seal over thedressing assembly; and a reduced-pressure subsystem for providingreduced pressure to the dressing assembly whereupon the system isoperable to generate a compressive force.
 63. The system of claim 62wherein the dressing assembly comprises a dressing bolster formed from abolster material and sized to extend over the desired treatment area andhaving a first surface and a second, inward-facing surface.
 64. Thesystem of claim 62 wherein the dressing assembly comprises: an interiorsurface member sized to extend over the desired treatment area andhaving a first surface and a second, inward-facing surface; and adressing bolster having a first surface and a second, inward-facingsurface, wherein the second, inward-facing surface of the dressingbolster is disposed against the first surface of the interior surfacemember.
 65. The system of claim 62 wherein the dressing assemblycomprises: an interior surface member having a first surface and asecond, inward-facing surface; a dressing bolster having a first surfaceand a second, inward-facing surface, wherein the second, inward-facingsurface of the dressing bolster is disposed against the first surface ofthe interior surface member; an exterior surface member having a firstsurface and a second, inward-facing surface, wherein the second,inward-facing surface of the exterior surface member is disposed againstthe first surface of the dressing bolster; and wherein the interiorsurface member and the exterior surface member are coupled to provide afluid seal over the dressing bolster.
 66. The system of claim 62 whereinthe dressing assembly comprises: an interior surface member sized toextend over the desired treatment area and having a first surface and asecond, inward-facing surface; a dressing bolster having a first surfaceand a second, inward-facing surface, wherein the second, inward-facingsurface of the dressing bolster is disposed against the first surface ofthe interior surface member; and wherein the dressing bolster comprisesan anisotropic bolster material having a first, second, and third axes,and wherein tension applied on the first axis causes a greater than 1:1response of the anisotropic bolster material along the second axis. 67.The system of claim 62 wherein the dressing assembly comprises: aninterior surface member sized to extend over the desired treatment areaand having a first surface and a second, inward-facing surface; adressing bolster having a first surface and a second, inward-facingsurface, wherein the second, inward-facing surface of the dressingbolster is disposed against the first surface of the interior surfacemember; and wherein the interior surface member comprises an elasticmaterial.
 68. The system of claim 62 wherein the dressing assemblycomprises: an interior surface member sized to extend over the desiredtreatment area and having a first surface and a second, inward-facingsurface; a dressing bolster having a first surface and a second,inward-facing surface, wherein the second, inward-facing surface of thedressing bolster is disposed against the first surface of the interiorsurface member; and wherein the interior surface member comprisesspandex.
 69. The system of claim 62 wherein the dressing assemblycomprises: an interior surface member having a first surface and asecond, inward-facing surface; a dressing bolster having a first surfaceand a second, inward-facing surface, wherein the second, inward-facingsurface of the dressing bolster is disposed against the first surface ofthe interior surface member; and an exterior surface member having afirst surface and a second, inward-facing surface, wherein the second,inward-facing surface of the exterior surface member is disposed againstthe first surface of the dressing bolster; and wherein the exteriorsurface member comprises an elastic material.
 70. The system of claim 62wherein the dressing assembly comprises: an interior surface memberhaving a first surface and a second, inward-facing surface; a dressingbolster having a first surface and a second, inward-facing surface,wherein the second, inward-facing surface of the dressing bolster isdisposed against the first surface of the interior surface member; andan exterior surface member having a first surface and a second,inward-facing surface, wherein the second, inward-facing surface of theexterior surface member is disposed against the first surface of thedressing bolster; and wherein the exterior surface member comprisesspandex.
 71. The system of claim 62 wherein the dressing assemblycomprises: an interior surface member having a first surface and asecond, inward-facing surface; a dressing bolster having a first surfaceand a second, inward-facing surface, wherein the second, inward-facingsurface of the dressing bolster is coupled to the first surface of theinterior surface member; and an exterior surface member having a firstsurface and a second, inward-facing surface, wherein the second,inward-facing surface of the exterior surface member is coupled to thefirst surface of the dressing bolster.
 72. The system of claim 62wherein the dressing assembly comprises: an interior surface memberhaving a first surface and a second, inward-facing surface and sized toextend over a desired treatment area; a dressing bolster sized to extendover a desired treatment area and having a first surface and a second,inward-facing surface, wherein the second surface of the dressingbolster is disposed against the first surface of the interior surfacemember; and an exterior surface member having a first surface and asecond, inward-facing surface, wherein the second, inward-facing surfaceof the exterior surface member is disposed against the first surface ofthe dressing bolster.
 73. The system of claim 62 wherein the sealingsubsystem comprises: an outer sealing member associated with thedressing bolster; and a sealing apparatus for providing the fluid sealbetween an epidermis of the patient and the outer sealing member. 74.The system of claim 62 wherein the reduced-pressure subsystem comprises:a reduced-pressure source for providing a reduced pressure; areduced-pressure interface coupled to the sealing subsystem; areduced-pressure delivery conduit for providing reduced pressure fromthe reduced-pressure source to the reduced-pressure interface.
 75. Amethod for providing a force to a curved body part, the methodcomprising the steps of: placing a dressing assembly against a desiredtreatment area; wherein the dressing assembly has a longitudinal portionwith a first end and a second end; releasably coupling the first end tothe second end to hold the longitudinal portion of the dressing assemblyagainst the patient in the desired treatment area; fluidly coupling areduced-pressure source to the dressing assembly; and activating thereduced pressure source to provide reduced pressure to the dressingassembly, whereby the dressing assembly is placed under reduced pressureand contracts to form a directed force.
 76. The method of claim 75,wherein the dressing assembly comprises a dressing bolster formed from abolster material having a density greater than 25 kg/m3.
 77. The methodof claim 75, wherein the dressing assembly comprises a dressing bolsterformed from a bolster material having a density less than a densityepidermis and wherein the directed force is a lifting force.